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Cannabinoid Folks, Pay Attention to Kratom

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It seems as if there is a new cannabinoid product coming out every five minutes. Scratch that – it seems like there is a new cannabinoid coming out every five minutes. After CBD, it was CBG and CBN, then the deltas, and then, well, it’s hard to keep track. Today, every time I research these new cannabinoids, I inevitably see ones I have never heard of before.

People constantly ask me how X cannabinoid will be regulated. What I generally say is that in most cases, there will be no federal or state law that specifically deals with that cannabinoid. But there are are basically three things I think are important to consider here.

In a post on August 3, 2023, hemp lawyer Rod Kight analyzed new cannabinoid H4 CBD – one I’d never stumbled into before. In that post, he analyzed two of the key questions at issue – first, whether H4 CBD is deemed “THC” under the Controlled Substances Act; and second, whether H4 CBD could qualify as a new dietary ingredient (NDI) under the Food Drug and Cosmetic Act (FDCA). I think it is also key to consider state law and whether it imposes restrictions beyond the CSA and NDI process. I’m sure Rod thinks about this too, although it’s hard to cover everything in a short blog post!

Today I want to talk about the NDI issue and expand on it a little further. If someone wants to put a new substance (say, a newly discovered/developed cannabinoid) into a dietary supplement), it will be considered an NDI. The manufacturer will have to provide FDA with information that the NDI is safe. My understanding is that folks tried this in the early days with CBD, but that the agency rejected these efforts.

But CBD isn’t the best analogy for some of these newer cannabinoids – especially for the intoxicating and/or synthetic ones. For one, CBD isn’t intoxicating. For another, it was approved in the form of Epidiolex®, meaning it couldn’t be a new dietary ingredient under the so-called Drug Exclusion Rule. I don’t want to go down that rabbit hole today, but you can read about it here if interested.

So if you want to know how FDA might handle something like this, a good place to start is with kratom. Kratom is in many senses very different from cannabinoids – it comes from Southeast Asia and has effects that are comparable to opioids. It’s not new or synthetic, as are a lot of the newer cannabinoids flooding the market. But, it can be intoxicating. And it is not on the CSA (the DEA tried and then backed off efforts to schedule it in 2016). And it can reportedly be dangerous, although I’m sure some of you would point out that some of the vape deaths a few years ago were reportedly caused by synthetic cannabinoids.

But FDA isn’t deterred. Here is what it says on its website currently:

Kratom is not appropriate for use as a dietary conventional supplement. FDA has concluded from available information, including scientific data, that kratom is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury and, therefore, dietary supplements that are or contain kratom are adulterated under section 402(f)(1)(B) of the FD&C Act. Further, FDA has determined that kratom, when added to food, is an unsafe food additive within the meaning of section 409; food containing an unsafe food additive, such as kratom, is adulterated under section 402(a)(2)(C)(i). Based on these determinations by FDA, kratom is not lawfully marketed as a dietary supplement and cannot be lawfully added to conventional foods.

That’s a lot to unpack. Basically, according to FDA, there isn’t sufficient information to show that kratom is safe, so it cannot be an NDI. And as we’ll come back to in a moment, this is quite an understatement of FDA’s position, which is that kratom is incredibly harmful.

Turning back to the above quote, let’s hone in on the word “adulterated.” The import, sale, distribution, etc. of adulterants or adulterated products can lead to civil and criminal penalties galore under the FDCA. FDA is pretty aggressive when it comes to kratom, as opposed to its occasional warning letter for CBD. Take this FDA press release from April 2023 for example:

On Wednesday the U.S. Marshals, at the FDA’s request, seized more than 250,000 units of dietary supplements and bulk dietary ingredients that are or contain kratom, including over 1000 kilograms of bulk kratom. . . The seized products are worth approximately $3 million. The U.S. Department of Justice, on behalf of the FDA, filed a complaint in the U.S. District Court for the Northern District of Oklahoma alleging, among other things, that kratom is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that it does not present a significant or unreasonable risk of illness or injury; therefore, dietary supplements and bulk dietary ingredients that are or contain kratom are adulterated under the Federal Food, Drug, and Cosmetic Act.

FDA will still have to prove its case in court, but the point here is that it IS GOING to court. In the last five years, how many times have we seen that with CBD?

Now, you may be thinking to yourself, “kratom is a lot different from cannabinoids.” I agree. I’m not here to say things are apples to apples. But what I can say is that the NDI process effectively puts the onus on manufacturers to prove something is safe, with FDA having ultimate gatekeeping authority. Just look at how FDA talks about delta-8 THC, an intoxicating cannabinoid, and it’s not hard to see the agency taking the same or even a kratom-esque position with respect to lab-created, intoxicating cannabinoids. If Congress doesn’t address this in the upcoming farm bill, expect FDA to.

One last point about kratom that could inform the future of cannabinoid regulation – states often fill a vacuum created by the federal government’s inaction. When DEA opted not to schedule kratom, a number of states did schedule the substance (and a number went the other way, passing various kratom consumer protection acts). Actual consumers have no idea about the patchwork of directly opposite state laws, so we see things like people buying kratom legally in Florida, driving home to Alabama where it is illegal, and getting arrested along the way. Check out this Tweet thread for an example of some of the shocking potential prosecutions that are being reported based on this example alone.

This is relevant to the cannabinoid market, because the same thing is going to start to happen at the state level. We saw it happen years ago with states banning smokable hemp. Then it was delta-8 THC bans. This is going to keep happening. And people are going to keep getting arrested.

The bottom line here is that the future of hemp cannabinoid regulations is going to be messy. Nobody knows exactly what things will look like after the next farm bill, but my guess is that this Congress doesn’t do a great job (shocking prediction, right?) and we get left with occasional FDA intervention and a wildly shifting state-level framework, just like with kratom. Let’s hope I’m wrong and Congress buttons this issue up right – but I don’t have high hopes on this one.





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Webinar Replay: Post-Election Cannabis Wrap – Smoke ’em if You’ve Got ’em

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On Thursday, November 7th, Vince Sliwoski, Aaron Pelley and Fred Rocafort held a post election discussion “Post-Election Cannabis Wrap – Smoke ’em if You’ve Got ’em”. Watch the replay!

Key Takeaways from the “Smoke ’em if You’ve Got ’em – 2024 Post Election Cannabis Wrap” Webinar:

  1. Panelists:
    • Vince Sliwoski: Oregon Business lawyer specializing in cannabis and commercial real estate.
    • Aaron Pelley: Experienced in cannabis law since Washington’s legalization in 2012.
    • Fred Rocafort: Trademark attorney working closely with the cannabis team.
  2. Election Results Overview:
    • Most 2024 cannabis ballot measures did not pass.
    • Florida, South Dakota, and North Dakota saw failures.
    • Nebraska became the 39th state to legalize cannabis for medical use when it passed two cannabis initiatives, Initiatives 437 and 438.
  3. Federal and State-Level Developments:
    • Medical use is currently legal in 38 states, and 24 states allow recreational use.
    • Republican support for marijuana legalization is growing.
  4. Federal Policy Implications:
    • Schedule III Rescheduling: The process to move cannabis to Schedule III is ongoing, which could significantly impact the industry.
    • Importance of Federal Appointments: The future of cannabis policy depends heavily on who is appointed to key positions in the administration.
  5. International and Domestic Trade:
    • Schedule III status could ease import/export restrictions on cannabis.
    • Unified control of House, Senate, and presidency might expedite legislative progress.
  6. Economic and Industry Impact:
    • Cannabis stocks experienced volatility post-election, reflecting investor uncertainty.
    • Federal legalization and banking reforms are crucial for industry stability and growth.
  7. Future Outlook:
    • The potential for federal rescheduling remains strong, with hearings scheduled for early 2025.
    • State-level initiatives and regulatory developments will continue to shape the industry.

Watch the replay!



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I Had Just One Puff

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one puff of a joint a drug test

“How Long Does One Puff of Weed Stay in Your System?”… This topic can be difficult to answer since it is dependent on elements such as the size of the hit and what constitutes a “one hit.” If you take a large bong pull then cough, it might linger in your system for 5-7 days. A moderate dose from a joint can last 3-5 days, whereas a few hits from a vaporizer may last 1-3 days.

 

The length of time that marijuana stays in the body varies based on a number of factors, including metabolism, THC levels, frequency of use, and hydration.

 

Delta-9-tetrahydrocannabinol, or THC, is the primary psychoactive component of cannabis. THC and its metabolites, which remain in your body long after the effects have subsided, are detected by drug tests.

 

Since these metabolites are fat-soluble, they cling to bodily fat molecules. They could thus take a while to fully pass through your system, particularly if your body fat percentage is higher.

 

THC is absorbed by tissues and organs (including the brain, heart, and fat) and converted by the liver into chemicals such as 11-hydroxy-THC and carboxy-THC. Cannabis is eliminated in feces at a rate of around 65%, while urine accounts for 20%. The leftover amount might be kept within the body.

 

THC deposited in bodily tissues ultimately re-enters the circulation and is processed by the liver. For frequent users, THC accumulates in fatty tissues quicker than it can be removed, thus it may be detectable in drug tests for days or weeks following consumption.

 

The detection time varies according to the amount and frequency of cannabis usage. Higher dosages and regular usage result in longer detection times.

 

The type of drug test also affects detection windows. Blood and saliva tests typically detect cannabis metabolites for shorter periods, while urine and hair samples can reveal use for weeks or even months. In some cases, hair tests have detected cannabis use over 90 days after consumption.

 

Detection Windows for Various Cannabis Drug Tests

 

Urine Tests

Among all drug tests, urine testing is the most commonly used method for screening for drug use in an individual.

 

Detection times vary, but a 2017 review suggests the following windows for cannabis in urine after last use:

 

– Single-use (e.g., one joint): up to 3 days

– Moderate use (around 4 times a week): 5–7 days

– Chronic use (daily): 10–15 days

– Chronic heavy use (multiple times daily): over 30 days

 

Blood Tests

Blood tests generally detect recent cannabis use, typically within 2–12 hours after consumption. However, in cases of heavy use, cannabis has been detected up to 30 days later. Chronic heavy use can extend the detection period in the bloodstream.

 

Saliva Tests

THC can enter saliva through secondhand cannabis smoke, but THC metabolites are only present if you’ve personally smoked or ingested cannabis.

 

Saliva testing has a short detection window and can sometimes identify cannabis use on the same day. A 2020 review found that THC was detectable in the saliva of frequent users for up to 72 hours after use, and it may remain in saliva longer than in blood following recent use.

 

In areas where cannabis is illegal, saliva testing is often used for roadside screenings.

 

Hair Tests

Hair follicle tests can detect cannabis use for up to 90 days. After use, cannabinoids reach the hair follicles through small blood vessels and from sebum and sweat surrounding the hair.

 

Hair grows at approximately 0.5 inches per month, so a 1.5-inch segment of hair close to the scalp can reveal cannabis use over the past three months.

 

Factors Affecting THC and Metabolite Retention

 

The length of time THC and its metabolites stay in your system depends on various factors. Some, like body mass index (BMI) and metabolic rate, relate to individual body processing, not the drug itself.

 

Other factors are specific to cannabis use, including:

 

– Dosage: How much you consume

– Frequency: How often you use cannabis

– Method of consumption: Smoking, dabbing, edibles, or sublingual

– THC potency: Higher potency can extend detection time

 

Higher doses and more frequent use generally extend THC retention. Cannabis consumed orally may remain in the system slightly longer than smoked cannabis, and stronger cannabis strains, higher in THC, may also stay detectable for a longer period.

 

How Quickly Do the Effects of Cannabis Set In?

 

When smoking cannabis, effects appear almost immediately, while ingested cannabis may take 1–3 hours to peak.

 

The psychoactive component THC produces a “high” with common effects such as:

 

– Altered senses, including perception of time

– Mood changes

– Difficulty with thinking and problem-solving

– Impaired memory

 

Other short-term effects can include:

– Anxiety and confusion

– Decreased coordination

– Dry mouth and eyes

– Nausea or lightheadedness

– Trouble focusing

– Increased appetite

– Rapid heart rate

– Restlessness and sleepiness

 

In rare cases, high doses may lead to hallucinations, delusions, or acute psychosis.

 

Regular cannabis use may have additional mental and physical effects. While research is ongoing, cannabis use may increase the risk of:

 

– Cognitive issues like memory loss

– Cardiovascular problems including heart disease and stroke

– Respiratory illnesses such as bronchitis or lung infections

– Mood disorders like depression and anxiety

 

Cannabis use during pregnancy can negatively impact fetal growth and development.

 

Duration of Effects

Short-term effects generally taper off within 1–3 hours, but for chronic users, some long-term effects may last days, weeks, or even months. Certain effects may even be permanent.

 

Bottom Line

The amount of time that cannabis remains in your system following a single use varies greatly depending on individual characteristics such as body fat, metabolism, frequency of use, and mode of intake. Frequent users may maintain traces of THC for weeks, whereas infrequent users may test positive for as little as a few days. Hair tests can disclose usage for up to 90 days, while blood and saliva tests identify more recent use. Urine tests are the most popular and have varying detection durations. The duration that THC and its metabolites are detectable will ultimately depend on a number of factors, including dose, strength, and individual body chemistry.

 

PEE IN A CUP COMING UP, READ ON..

how long does weed stay in your urine

HOW LONG DOES WEED STAY IN YOUR URINE FOR A DRUG TEST?



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Is Kratom Addictive? Understanding Dependence, Risks, and Safe Usage

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is kratom addictive

Is kratom addictive? Discover the potential for dependence on Kratom, the risks involved with its use, and how to approach its consumption responsibly.

From 2011 to 2017, over 1,800 calls to poison centers involved kratom in the U.S. This significant number highlights the concern regarding kratom addiction.

However, without Food and Drug Administration (FDA) oversight, and due to various consumption methods like teas and capsules, there are significant health risks. Safe use of kratom is now in question due to these issues.

Research debates how dependence develops, outlining signs like loss of control and withdrawal symptoms. These signs are seen in regular kratom users. Ironically, some people switch from drugs like heroin to kratom, looking for a legal alternative.

Understanding Kratom: Origins and Prevalence

Kratom comes from the Mitragyna speciosa tree in Southeast Asia. It can act like a stimulant or like opioids, based on how much you take. People use it in different ways, for a small energy boost or stronger effects at higher doses.

The legal status of kratom in the U.S. is complicated and changing. It’s a hot topic because some worry about its misuse. It’s still legal in several states. This shows how different places handle drug rules. The National Institute on Drug Abuse is looking into its medical benefits. But, the FDA hasn’t approved it for medical use yet. The DEA calls it a “drug of concern,” which means policies might change.

  • From 2011 to 2017, poison control centers in the U.S. got over 1,800 reports about kratom. This shows it’s widely used and might pose health risks.

  • Kratom’s main ingredients bind to opioid receptors very strongly, stronger than morphine even. This fact is key to understanding its effects.

  • As more people use kratom, more are reporting serious health problems. These include liver and heart issues, and tough withdrawal symptoms, particularly in those already sick.

The statistics show mounting worries about kratom in the U.S. As its use grows, it’s becoming more important to health policies and laws. What happens next will depend on further research and legal decisions.

Is Kratom Addictive: Investigating the Substance’s Nature

The question of kratom’s addictiveness focuses on how it affects brain receptors and its long-term health implications. The ongoing debate highlights concerns about dependence and the risk of addiction. Scientists are closely looking at these issues.

How Kratom Works in the Brain

Kratom’s main alkaloids, mitragynine and 7-hydroxymitragynine, bind to the brain’s opioid receptors, similar to painkillers and narcotics. This connection suggests a potential risk of dependence. These alkaloids are key to kratom’s pain relief but also point to possible addiction concerns, especially with frequent, high-dose usage.

Patterns and Consequences of Long-term Use

  • Using kratom often, especially in large doses, can increase the risk of dependence and intense withdrawal symptoms, similar to opioid withdrawal.

  • Although some use it for pain or to improve mood, long-term kratom users might see serious health problems, like liver damage and mental health issues.

  • Withdrawal symptoms, including irritability, nausea, and sleep problems, show kratom’s impact on one’s physical and mental health.

Assessment of Addiction Risks

Studies indicate a significant risk of addiction to kratom, especially with high doses or frequent use. Dependence develops as the body gets used to kratom, leading to tolerance and a need for more to feel its effects. Withdrawal symptoms emphasize this risk, as highlighted by health experts.

Physiological Effects: Kratom’s Impact on the Body

There is a lot of debate about the safety and use of kratom. This herbal extract comes from the Mitragyna speciosa plant. It has drawn attention for its possible harmful effects on the body. The FDA has issued many warnings about kratom, raising safety concerns.

  • Kratom Adverse Effects: Kratom users have reported side effects like nausea, vomiting, and confusion. More serious issues include high blood pressure and liver damage. These problems highlight the risks of using kratom.

  • Herbal Extract Safety: Some kratom products contain heavy metals and pathogens. These can cause severe health issues, including death. This shows the importance of safety in herbal products.

  • FDA Warnings and Regulations: The FDA has linked kratom to over 35 deaths and warns against using it. They point out the lack of medical uses and the risk of addiction.

  • Physiological Impact: Kratom’s effects depend on the dose and the user’s body. Yet, it can lead to dangerous outcomes like liver damage and seizures.

  • Safety Concerns from Authorities: Federal agencies like the DEA are worried about kratom’s safety. Although not a controlled substance, monitoring suggests users should be careful.

Kratom might offer temporary relief for some ailments, but it comes with significant risks. The FDA’s warnings should make people think twice. If considering kratom, it’s crucial to talk to a doctor first. Experts stress the need for safety and caution with herbal extracts.

Conclusion

Kratom’s role in health and regulation is complex, with views and research findings widely varied. Some people use kratom for its claimed health benefits, but it’s a hot topic. Experts advise caution and suggest consulting a doctor before using kratom due to the unclear effects.

Clinical studies using scores like SOWS and COWS haven’t confirmed withdrawal symptoms from kratom. This adds to the debate, especially when some users report withdrawal. This makes kratom a controversial subject among different findings and user experiences.

When it comes to treating opioid addiction, kratom can be both helpful and harmful. Some have used it successfully to fight addiction. Yet, some states have banned it. This highlights the need for regulations and consistent product quality. It also raises questions about kratom’s legal status due to mixed actions by authorities.

The situation shows how complex kratom is in the realm of substance use and law. Without clear evidence supporting either its benefits or risks, it poses a challenge. More research is needed to guide regulations and health advice. For now, anyone thinking of using kratom should be careful, seek medical advice, and keep up with laws and health guidelines.

 

WHAT IS KRATOM ANYWAY? READ ON…

WHAT IS KRATOM

WHAT IS KRATOM AND WHY ARE YOU HEARING ABOUT IT NOW?



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